June 21, 2021

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Kloxxado, a Higher Dose Naloxone Nasal Spray, Gets FDA Approval

The Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for KloxxadoTM (naloxone hydrochloride) nasal spray for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Kloxxado is an opioid antagonist that delivers 8mg of naloxone per spray into the nasal cavity compared with the previously approved 2mg and 4mg naloxone nasal spray products currently on the market. Kloxxado is intended for immediate administration as emergency therapy in settings where opioids may be present.

The application was submitted under the FDA’s 505(b)(2) approval pathway which relied, in part, on the safety and efficacy of naloxone hydrochloride (Narcan injection) to support approval. The approval was also supported by Kloxxado-specific pharmacokinetic data, which established the safety and efficacy of the product.


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Kloxxado is expected to be available in the second half of 2021.

“Today’s action meets another critical need in combatting opioid overdose,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most.”

The Agency has taken several steps to improve naloxone availability over the years, including requiring drug manufacturers to add new naloxone recommendations to the prescribing information for all opioid medications and extending the shelf life of naloxone nasal spray (Narcan) from 24 months to 36 months.

References

  1. Hikma announces US FDA approval of KloxxadoTM (naloxone hydrochloride) nasal spray 8mg. [press release]. London, UK: Hikma Pharmaceuticals USA Inc.; April 30, 2021. 
  2. FDA approves higher dosage of naloxone nasal spray to treat opioid overdose. [press release]. Silver Spring, MD: US Food and Drug Administration; April 30, 2021.

This article originally appeared on MPR